Actemra® (tocilizumab): New important identified risk of hepatotoxicity

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Description:

Actemra® (tocilizumab) is a biological product indicated for rheumatoid arthritis in adults, polyarticular systemic juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA) in patients above 2 years old, as well as giant cell arteritis (GCA) in adults.

 

Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, which in some cases required liver transplant, have been observed with the use of Actemra®.

Several measures should be considered in patients receiving Actemra®, as follows:

  • All healthcare professionals are advised to monitor the ALT and AST levels of their patients every 4 to 8 weeks for the first 6 months of Actemra® treatment, followed by every 12 weeks thereafter for all approved indications.
  • Exercise caution when initiating Actemra® treatment in patients with ALT or AST >1.5 times the upper limit of normal (ULN). Treatment is not recommended in patients with ALT or AST >5 times ULN.
  • Recommended dose modifications of Actemra® due to the liver enzyme abnormalities remain unchanged. Please refer to the product information for full prescribing details.

 

NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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